Clinical Data Standards Management Specialist

We are working with a niche CRO headquartered in Germany who are looking to hire a Clinical Data Management Standards Specialist to join them on a permanent basis.

There is a requirement within this role to work onsite at their office in the Ruhr area at least 1 day per week. *Within this role, your primary responsibilities will include : Project management of the working group for the conception and further development of a reporting system for data quality* Reporting to the client's management on the status of the clinical data standards working groups* Standardisation of data management and clinical programming processes* Supervision of overall data quality Distribution of clinical data standards for internal users and CROs Surveillance of data integration and data modelling* Leading the development of data visualisation tools Leading the programming of clinical trials and regulatory submissions*What you can bring to the role : A Masters degree or PhD in statistics, data science, computer science, mathematics, bioinformatics, or other related fields.

• At least 7 years of experience in clinical data management and / or statistical programming in a CRO / pharma environment* Comprehensive understanding of data management processes and standards as well as current regulatory requirements for data management* Knowledge of at least one common CDMS and preferably experience in working with an EDC platform (Medidata Rave preferred) CDISC Standards (CDASH, SDTM, ADaM) expertise*What you get in return : Transparent salary policy and comprehensive reward and benefit system* An environment dedicated to sustainability* An ambitious team that works with passion and flexibility* Flexible, family-friendly work time and hybrid working arrangements* Further education for personal and professional development* Wide range of corporate health services
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